FDA-Device2025-05-21Class II
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
Abbott Molecular, Inc.
Hazard
There were reports of an increase in reactive negative controls and false positive results.
Sold states
Worldwide - US Nationwide distribution.
Affected count
1447 units
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1748-2025Don't want to check this manually?
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